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Mobility Interventions for Lower Limb Amputation

N/A
Recruiting
Led By Peter G Adamczyk, Ph.D.
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must be able to walk with their prostheses or orthoses for 30 minutes (total) and stand for 30 minutes (total), in individual bouts of at least 6 minutes, without becoming fatigued, feeling dizzy, having chest pain or shortness of breath, or experiencing claudication symptoms.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 10 days, and 20 days for orthotic interventions, weekly time points for prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study
Awards & highlights

Study Summary

This trial tests the comparative biomechanical benefits of different lower-limb prostheses and orthoses.

Who is the study for?
This trial is for individuals with lower limb amputation or foot drop who have been using a prosthesis or orthosis for over 6 months, can wear it all day, and perform daily activities. They must be in good health, able to walk and stand for specified durations without issues, fluent in English, and not currently receiving certain treatments that could affect the study.Check my eligibility
What is being tested?
The study tests different lower-limb prostheses and orthoses' biomechanical benefits during everyday life using wearable sensors. It aims to improve physical health, activity levels, independence, workforce participation, and mental health of participants by comparing movement patterns with various device designs.See study design
What are the potential side effects?
There are no direct side effects mentioned from participating in this trial as it involves non-invasive monitoring of mobility. However, there may be general risks associated with increased physical activity such as muscle soreness or fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can walk and stand with my prosthesis or orthosis for 30 minutes without feeling unwell.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 10 days, and 20 days for orthotic interventions, weekly time points for prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 10 days, and 20 days for orthotic interventions, weekly time points for prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Difference in stride length at identical walking speed
Secondary outcome measures
Behavioral gait function as measured from daily stride count
Behavioral gait function as measured from preferred stride speed
Change in 6 minute Walking Test Distance
+8 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Prosthesis user with transtibial or transfemoral amputationExperimental Treatment1 Intervention
Experiments will use standard commercially available prostheses for participants with lower-limb amputation. Specific prostheses will be determined at the time of the study, but they will include prostheses that are fully passive such as energy storage-and-return (ESR) feet, ESR feet with mobilized ankles such as passive hydraulic ankles (PHA), and ESR feet with microprocessor-controlled ankles (MPA).
Group II: Orthoses user with drop-footExperimental Treatment1 Intervention
This arm will consists of participants with drop-foot. A subset of the drop-foot population will be persons with Multiple Sclerosis and currently drop-foot. For participants in this arm, standard commercially-available orthoses or standard-of-care custom orthoses will be used, as well as standard commercially-available electrical stimulation neuro-orthoses.
Group III: Healthy controlsExperimental Treatment1 Intervention
The Control participants are for methods development and do not constitute a formal study group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Footwear
2021
N/A
~180

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor
1,183 Previous Clinical Trials
3,167,504 Total Patients Enrolled
United States Department of DefenseFED
863 Previous Clinical Trials
227,582 Total Patients Enrolled
1 Trials studying Lower Limb Amputation
30 Patients Enrolled for Lower Limb Amputation
Peter G Adamczyk, Ph.D.Principal InvestigatorUniversity of Wisconsin, Madison
1 Previous Clinical Trials
44 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does my current medical status qualify me to join this research initiative?

"For eligibility in this study, individuals must have foot drop and be between 18-75 years old. A maximum of 50 volunteers will be accepted into the experiment."

Answered by AI

What is the upper limit of participants enrolled in this experiment?

"Affirmative. Clinicaltrials.gov displays that the trial, initiated on September 3rd 2021, is still searching for patients to participate in this experiment. The team needs 50 volunteers from 1 research centre."

Answered by AI

Are there any current openings to join this experiment?

"Affirmative, clinicaltrials.gov reports that this medical trial is presently recruiting patients. It was initially posted on September 3rd 2021 and the most recent update was made November 21st 2022; 50 people are required from one location."

Answered by AI

Is enrollment open to individuals who are not octogenarians?

"The minimum age to join this medical trial is 18 and the maximum age is 75. Additionally, there are 9 other studies targeting patients under 18 or older than 65 years of age."

Answered by AI

Who else is applying?

What state do they live in?
Ohio
South Dakota
New Jersey
How old are they?
18 - 65
What site did they apply to?
University of Wisconsin
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
clinicaltrials.govStudy
Evaluating Mobility Interventions in the Real World
2021. "Evaluating Mobility Interventions in the Real World". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04275973.
~6 spots leftby Sep 2024
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